Specialist, Research Quality Assurance - FT - Days - MHS

Memorial Healthcare System is hiring a Research Quality Assurance Specialist to support its clinical research program by ensuring research activities comply with regulations, institutional policies, and ethical standards. The role provides quality oversight through audits and monitoring, supports inspection readiness, and trains research personnel.

Responsibilities

• Schedules, coordinates and conducts project specific audits related to allegations of research non-compliance, high risk, high enrollment, or randomly selected investigator protocols, including providing monitoring for investigator initiated trials and preparation for external audits
• Performs source data verification of research related documentation (e.g., investigator qualifications, staff training, Electronic Medical Record, etc.), issuing queries as needed, to ensure proper adherence to SOPs and applicable regulatory requirements
• Generates monitoring reports and communicates monitoring results to Principal Investigators, research teams, and departmental leadership. Manages post-monitoring activities and follows-up on necessary corrective and preventive actions. Escalates unacceptable findings to institutional leadership. Assists with the filing of Protocol Deviations and Serious Adverse Event reporting
• Develops, updates, and maintains educational materials for research staff, including presentations, guides, and training modules. Collaborates with IT teams to support the conversion of educational content into digital formats for e learning platforms. Delivers in-person and virtual training sessions for investigators, coordinators, regulatory staff, pharmacists, APPs, residents, fellows, and other research personnel. Ensures training content aligns with research standards, regulatory requirements, and institutional policies
• Reviews Informed Consent and Assent Forms (ICFs) for completeness, accuracy, and compliance with regulatory and institutional requirements. Identifies errors or deviations and ensures timely correction and documentation
• Provides ongoing QA/QC support to research teams to ensure high quality documentation and data integrity. Assists in identifying process gaps and recommends improvements to enhance research operations. Supports risk assessments, root cause analyses, and continuous quality improvement initiatives. Promotes a culture of compliance, ethical conduct, and research integrity across the institution

Preferred

• Oncology and/or Hematology research experience strongly preferred
• Bachelor's degree in science, healthcare, or a related medical field
• RN degree preferred
• Knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database preferred
• Familiarity with NCI CTSU systems, cooperative group research processes, for Clinical Trials in Oncology requirements preferred
• SOCRA (CCRP) or (ACRP) certification preferred
• Oncology Research
• Hematology Research
• Registered Nurse (RN)
• Complion
• Epic
• REDCap
• NCI CTSU Systems
• Cooperative Group Research
• Oncology Clinical Trials
• SOCRA CCRP Certification
• ACRP Certification

Company

• Not-for-profit health system providing personalized patient care.
• Easton, Maryland, USA
• http://www.memorialregional.com/
• Founded in 1953
• 10001+ employees

Qualifications

• Bachelors (Required)
• Thorough knowledge of regulatory requirements for clinical research, including ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs
• Knowledge of basic human anatomy, physiology, and medical terminology
• A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required
• Oncology and/or Hematology research experience strongly preferred
• Bachelor's degree in science, healthcare, or a related medical field
• RN degree preferred
• Knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database preferred
• Familiarity with NCI CTSU systems, cooperative group research processes, for Clinical Trials in Oncology requirements preferred
• SOCRA (CCRP) or (ACRP) certification preferred
• A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required.

Required skills

• Clinical Research Monitoring and Auditing, Clinical Research Quality Assurance/Quality Control, ICH Good Clinical Practice (GCP), FDA Code of Federal Regulations (CFR), HIPAA, IRB Processes, Institutional SOPs, Complion, Epic, REDCap, NCI CTSU Systems, SOCRA CCRP or ACRP Certification

Preferred skills

• RN degree preferred, SOCRA (CCRP) or (ACRP) certification preferred, Easton, Maryland, USA, http://www.memorialregional.com, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, 51, Represents job field similar to this job, Engineering and Development, Customer Service and Support, Education and Training, Management and Executive, Trends of Total Sponsorships, *2026, (6), 2025, (7), 2024, (15), 2023, (4), 2022, (3), 2021, 2020, Late Stage, Leadership Team, Paul Gaden, Chief Executive Officer, Memorial Regional Hospital

Experience

• 3+ years